Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT02158494
Eligibility Criteria:
Inclusion Criteria:
* All candidates will have a balance disorder as a result of a traumatic brain injury (TBI).
* All candidates will have a NeuroCom® Sensory Organization Test (SOT) composite score at least 8 points below normal after adjustment for age and height \[based on normative data\].
* All candidates will be between the ages of 18 and 65 (at the time of screening).
* If female of childbearing potential, the candidate agrees to use adequate contraception throughout participation in the study (from enrollment to completion).
* All candidates must have access to a treadmill.
* All candidates will be at least 1 year post-injury.
* All candidates will have a neuroradiologic scan and report after their most recent TBI.
* All candidates will be ambulatory and able to walk for 20 minutes.
* All candidates, if on medications, will not have had any major changes in type or dosage within 3 months of enrollment.
* All candidates will have participated in a focused physical rehabilitation program for their TBI and feel that they have reached a plateau.
* All candidates will be able to understand and willing to give informed consent.
Exclusion Criteria:
* All candidates that have oral health problems (e.g. gum disease, active cankers, piercings, oral surgery within the previous 3 months).
* All candidates with non-removable metal orthodontic devices (e.g., braces) or oral cavity piercings that could interfere with PoNS™ use.
* All candidates who have chronic infectious diseases (e.g. hepatitis, HIV, TB).
* All candidates with unmanaged hypertension.
* All candidates with unmanaged diabetes, or complications due to diabetes (e.g. retinopathy, neuropathy, renal disease).
* All candidates with neurological disorders other than those attributed to their primary diagnosis (e.g., MS, PD, ALS, AD or other dementia, uncontrolled pain).
* All candidates with a history of oral cancer.
* All candidates who have been treated for any type of cancer other than basal cell carcinoma within the past year.
* All candidates who have had a penetrating injury, craniotomy (with the exception of a burr hole \[trephination\] for resolution of acute subdural hematoma), or refractory subdural hematoma.
* Exceptions for other abnormalities identified in neuroradiologic scan reports that are asymptomatic and not expected to change may be made on a case by case basis by the Medical Advisor.
* All candidates with chronic use of psychoactive or psychostimulant medications that, in the opinion of the investigators, would compromise the subject's ability to comprehend and perform the study activities.
* All candidates who have a pacemaker, or are identified as at-risk for cardiovascular events.
* All candidates who are pregnant or lactating.
* All candidates with a lower extremity biomechanical prosthetic.
* All candidates with a history of seizures (except those in the acute or post-acute phases, and are controlled).
* All candidates who who experienced a loss of consciousness greater than 24 hours as a result of their TBI.
* All candidates with a "severe" score in any of the Attention, Memory, or Executive Functions categories on the Cognitive Linguistic Quick Test (CLQT).
* All candidates who, in the opinion of the investigators, are unable to feel the stimulation and successfully complete the device level setting procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02158494
Study Brief:
Protocol Section:
NCT02158494